According to a news report published on MedPageToday.com, the incidence of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is continuing to grow, and clinicians are noticing the disease’s diversity and finding that comprehensive care leads to optimal outcomes, according to a breast surgeon’s report.
As of the latter part of 2022, the global monitoring network of the American Society of Plastic Surgeons had documented 1,333 BIA-ALCL instances globally, along with 35 related fatalities. This total encompassed 402 cases and eight fatalities in the U.S. The FDA had been notified of 59 deaths, informed Kelly K. Hunt, MD, from the University of Texas MD Anderson Cancer Center in Houston, at the Miami Breast Cancer Conference.
“BIA-ALCL appears to be linked with textured breast implants, but not with smooth implants,” she commented. “The texture-creating process is believed to result in this disease, though its precise cause remains somewhat elusive. There are multiple theories, with a general consensus pointing towards the involvement of inflammatory cytokines production.”
Research conducted the previous year suggested that BIA-ALCL cases in the U.S. and elsewhere have been undercounted. However, the study only covered up until 2018. At the request of the FDA, Allergan pulled its textured implants off the market in 2019. Despite this, many women still have these implants as the FDA did not recommend their removal unless certain symptoms or signs of concern appeared.
A major development arose the previous year when the FDA issued a safety announcement stating that textured breast implants’ risks go beyond ALCL. Roughly 20 cases of squamous-cell carcinoma (SCC) and approximately 30 instances of B-cell lymphoma were found to be linked to these devices. The SCCs, which originated in the scar tissue (capsule) surrounding the implant, can be especially aggressive, noted Hunt.
“These instances are quite uncommon but are surfacing, and the number of reports appears to be increasing,” she further explained.
The connection between breast implants and ALCL was first revealed about 15 years ago with a report of roughly six instances of ALCL involving the breast, half of which were in women with breast implants. Further examination of literature revealed an additional 15 BIA-ALCL cases. The first identified case of BIA-ALCL was reported in 1997.
BIA-ALCL is considered a localized variant of ALCL, explained Hunt. Systemic ALCL is typically an aggressive disease requiring treatment with chemotherapy, immunotherapy, and stem cell transplantation. Systemic ALCL is linked with ALK rearrangement (ALK+), whereas ALK- disease often results in a poor prognosis. Localized ALK-ALCL includes primary cutaneous ALCL (typically less aggressive), BIA-ALCL, and mucosal ALCL.
Symptoms commonly linked with BIA-ALCL include late-onset fluid accumulation around the implant and increased breast size and sensitivity. Implant rupture can also lead to fluid buildup that could be misinterpreted as BIA-ALCL, Hunt noted. Some patients may have noticeable breast masses, signaling more advanced disease, while others might display axillary lymph node enlargement. Less frequently, BIA-ALCL patients may experience capsular contracture and alterations in breast shape.
The main treatment for BIA-ALCL is surgery, involving removal of the implant and the capsule, which in some instances seems to be curative without chemotherapy or radiotherapy. Comprehensive surgery, including capsulectomy, is linked with the best results and the least complications.
Taking Legal Action for Breast Implant Related BIA-ALCL
Taking legal action against a manufacturer for a defective product that leads to health issues is a step that many affected individuals may consider. In this context, for individuals who have developed breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), a product liability lawsuit may be an avenue to pursue.
Product liability refers to a manufacturer or seller being held liable for placing a defective product into the hands of a consumer. Responsibility for a product defect that causes injury lies with all sellers of the product who are in the distribution chain, which can include the manufacturer, the wholesaler, and the retail store owner.
For a successful product liability claim, three types of defects can be considered – design defects, manufacturing defects, and defects in marketing (failure to warn or improper instructions). In the case of breast implants, a design defect claim could argue that the very design of the implant is inherently dangerous, irrespective of the quality of its production. Manufacturing defect claims might assert that the issue arose during the manufacturing process, resulting in a product that deviates from the intended design. Marketing defect claims might argue that the manufacturers failed to provide adequate warnings about potential risks, or that they provided incorrect or insufficient instructions for safe use.
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